BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALCON LABORATORIES INC, ACRYSOFIQ

    MDR report key: 1345982 · Received March 16, 2009

    Report

    Report Number
    MW5010362
    Event Type
    Injury
    Date Received
    March 16, 2009
    Report Date
    March 16, 2009
    Manufacturer
    ALCON LAB, INC
    Product Code
    HQL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CATARACT SURGERY ALCON LABS EQUIPMENT WAS USED FOR MY SURGERY, I UNDERSTAND THEY KNEW OF PROBLEMS WITH THEIR EQUIPMENT. HAVE HAD TERRIBLE RESULTS SINCE PROCEDURE. I AM NOW HAVING THOSE IMPLANTS REMOVED AFTER 2 YEARS AND REPLACED. WE STILL DO NOT KNOW IF MY VISION WILL EVER BE THE SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCON LABORATORIES INC, ACRYSOFIQ CATARACT IMPLANTS HQL ALCON LAB, INC SN60WF

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other| R| S